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1+ months

Sr Quality Engineer

North Haven, CT 06473
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Sr Quality Engineer


North Haven, Connecticut, United States

Requisition #:


Post Date:

Aug 28, 2019

**Careers that Change Lives**


The Minimally Invasive Therapies Group strives to enable
earlier diagnosis, better treatment, faster complication-free recovery, and
enhanced patient outcomes through less invasive surgical solutions.

the standard for Minimally Invasive Surgery (MIS) by creating innovative
surgical products and services that focus on obesity and diseases and
conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region,
and the head and neck.

The Senior Quality Engineer is
responsible for a supporting and maintaining Quality System, managing/analyzing
customer complaints, conducting internal and external audits, and participates
in New Product Development to assure quality considerations are adequately
covered in the design, testing, and release of materials, components, and

**A Day in the Life**

Responsibilities may include the
following and other duties may be assigned.

1. Supports and maintains the
quality system and is able to make quality system recommendations and follow
through to implementation to address issues found.

2. Work with other departments to
resolve issues related to material and process quality, including FMEA, DOE.

3. Suggests recommendations on
quality concerns, trends and costs.

4. Perform Validations (IQ, OQ, PQ,
MSA, CQ) in accordance with company SOPs.

5. Ability to manage the customer
complaint system. Performs analysis of customer complaints. Initiate corrective
action requests on discrepant product/processes and verify adequacy and
accuracy of corrective action taken internally and/or externally.

6. Follow up on CAR effectiveness.

7. Schedules and conducts and/or
coordinates internal and external audits; prepares and issues summarized
reports; maintains quality surveillance of suppliers. Interface with supplier
quality representatives concerning problems with quality and assure that
effective corrective action is implemented.

8. Participates in New Product
Development to assure quality considerations are adequately covered in the
design, testing, and release of materials, components, and products.

9. Analyzes causes of defects and
recommends or leads teams who recommend corrective actions.

10.May supervise and schedule work
of Quality personnel and/or other subordinates as assigned.

11.Design methods for evaluating
product quality; establishes test programs to evaluate materials, processes and
products. Collect, analyze and interpret statistical data.

12.Develop Control Plans, Inspection
Instructions and other documents as needed to effectively manage
product/process quality.

13.Work with QA Technicians to
resolve measurement, blueprint/specification issues.

14.Develop and review documented
operating procedures associated with material inspection or processes.

**Must Have: Minimum Requirements**

+ Bachelors Degree in Engineering, Science or technicalfield with 4+ years of work experience in Engineering and/or Quality ORMasters Degree Engineering, Science or technical field with 2+ years ofwork experience in Engineering and/or Quality.

+ Process Validation and Root Cause Analysis (CAPA/NCR)experience a must.

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits
of what technology, therapies and services can do to help alleviate pain, restore
health and extend life. We challenge ourselves and each other to make
tomorrow better than yesterday. It is what makes this an exciting and rewarding
place to be.

We want to accelerate and advance our ability to create meaningful innovations
- but we will only succeed with the right people on our team. Lets work
together to address universal healthcare needs and improve patients lives.
Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job
description are representative of those that must be met by an employee to
successfully perform the essential functions of this job. Reasonable
accommodations may be made to enable individuals with disabilities to perform
the essential functions. For Office Roles: While performing the duties of this
job, the employee is regularly required to be independently mobile. The
employee is also required to interact with a computer and communicate with
peers and co-workers. Contact your manager or local HR to understand the Work
Conditions and Physical requirements that may be specific to each role.
(ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2019-08-30 Expires: 2020-02-07
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Sr Quality Engineer

North Haven, CT 06473

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